Catalog Number

-

Brand Name

Uterine ElevatOR Pro with OccludOR Balloon

Version/Model Number

UE-OBPRO-35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

c4fd04fd-26c7-44df-975a-9b3e79255102

Public Version Date

March 15, 2019

Public Version Number

1

DI Record Publish Date

March 07, 2019

Package DI Number

09349967003343

Quantity per Package

6

Contains DI Package

09349967003336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper box